Vaccine Safety: Active Monitoring Systems – FDA Sentinel’s PRISM
One of the most common misnomers and misinformation spread by anti-vaxxers is that the only vaccine safety monitoring systems are passive systems. They claim the only safety systems for vaccines require doctors and nurses to manually report vaccine reactions.
AVers constantly point to the Vaccine Adverse Event Reporting System or VAERS, pointing out that the number of events reported are really low, and many of the reported events are severe. While the VAERS is an important vaccine safety system for doctors and nurses to submit early signals for possible events that may be related to vaccines, active systems provide a better view of the frequency at which these events occur.
In the US, we have multiple active vaccine surveillance systems. The first system we are highlighting today is the FDA’s Sentinel Post-licensure Rapid Immunization Safety Monitoring or PRISM system.
PRISM collects data from 18 partner institutions throughout the United States, these Data Partners include the following institutions:
- Aetna, a CVS Health company
- Blue Cross Blue Shield of Massachusetts
- Duke University School of Medicine: Department of Population Health Sciences (100% Medicare Fee-For-Service data)
- Harvard Pilgrim Health Care Institute
- HCA Healthcare
- HealthCore, Inc (Anthem, Inc data)
- HealthPartners Institute
- Humana, Inc.
- Kaiser Permanente Colorado Institute for Health Research
- Kaiser Permanente Center for Health Research Hawaii
- Kaiser Foundation Health Plan of the Mid-Atlantic States, Inc.
- Kaiser Permanente Northern California, Division of Research
- Kaiser Permanente Northwest Center for Health Research
- Kaiser Permanente Washington Health Research Institute
- Marshfield Clinic Research Institute
- Optum (OptumInsight Life Sciences Inc. and Optum Labs®)
- Vanderbilt University Medical Center, Department of Health Policy (Tennesee Medicaid data)
As of 2018, PRISM had 70.1 million active persons in the system and over 310 million persons in the system between 2000 and 2018. This accounts for 15 billion encounters.
This system looks for the occurrence rates of adverse events based on the individuals encounters with any healthcare provider, hospital, and urgent care facilities.
Even if an event only occurs at a rate of one in a million, since the system includes over 310 million people, there should be enough individuals to capture even rare adverse events.
AVers do not want to acknowledge a system like PRISM exists, because acknowledging their existence means that you must reconcile beliefs with facts. AVers would need to reconcile their belief that serious events frequently occur with active monitoring systems which demonstrate otherwise. This is why AVers fixate on manual systems which they believe support their biases and deny active systems exist.
We will discuss the other active vaccine safety surveillance systems in further posts.